Treatment of large jaw cysts using endoscopy and navigation technology
A Single-arm, Single-center Clinical Study of Endoscopic Combined With Intraoperative Navigation-assisted Treatment of Giant Mandibular Cysts
This study is testing a new way to remove large jaw cysts using advanced technology to see if it causes less nerve damage compared to traditional surgery for adults aged 18 to 75.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06567535 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of endoscopic and intraoperative navigation techniques in the removal of giant mandibular bone cysts compared to traditional surgical methods. The primary focus is to reduce the rate of postoperative nerve injury, specifically targeting the inferior alveolar nerve. Patients aged 18 to 75 with odontogenic cystic lesions will undergo imaging examinations to confirm eligibility before receiving the innovative surgical treatment. The study will evaluate nerve function before and one month after surgery, with a secondary focus on recurrence rates one year post-operation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with large odontogenic cystic lesions in the mandible that affect the inferior alveolar nerve.
Not a fit: Patients with severe systemic diseases, pregnancy, or those unable to tolerate general anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the risk of nerve injury and recurrence for patients undergoing surgery for mandibular bone cysts.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in reducing nerve injury rates with advanced surgical techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. They are between 18 and 75 years old 2. Imaging and puncture pathology showed odontogenic cystic lesion of the mandible 3. Cystic lesions greater than or equal to 2cm in diameter and spread to the inferior alveolar nerve 4. New or recurrent cyst lesions, or odontogenic cystic lesions that are still greater than or equal to 2cm after other treatment such as fenestration and affecting the lower alveolar nerve 5. No serious systemic disease, tolerant of general anesthesia 6. Patients undergoing surgical treatment for mandibular bone cysts under general anesthesia 7. There was no inferior alveolar nerve injury before operation 8. Have not participated in other clinical trials within 30 days 9. Patients who volunteer to participate in the program and sign informed consent Exclusion Criteria: 1. The patient has severe systemic disease or pregnancy, and is judged to be unable to tolerate the course of this clinical study and cannot tolerate general anesthesia after evaluation by the research team and multidisciplinary consultation 2. Inability to complete the entire clinical research process due to personal, social, and economic reasons 3. Patients with psychiatric disorders or inability to perceive and communicate normally, such as schizophrenia, claustrophobia, etc., are unable to complete the examination and cooperate in the entire clinical research process
Where this trial is running
Guangzhou, Guangdong
- WangYan — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Yan Wang — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study coordinator: Yan Wang
- Email: wangy573@mail.sysu.edu.cn
- Phone: 13825119105
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.